Pr 589637 our manufacturing quality engineer received ten photos (10) for evaluation.It could be seen that the pouches are open on the sides, therefore, failure mode could be confirmed.A device history review was also performed for the reported lot numbers manufactured confirming procedural and functional requirements need for the product to be released were met.Although reported failure was confirmed through visual analysis a root cause could not be determined through this investigation.As a result a capa has been initiated.
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